On January 28, 2019, the U.S. Environmental Protection Agency (EPA) published its Year in Review: 2018 (YIR). The YIR lists the following accomplishments:

• Issued major proposals, including the Affordable Clean Energy Rule, the Safer Affordable Fuel-Efficient (SAFE) Vehicles Rule, and the new waters of the U.S. definition;
   
• Provided greater regulatory certainty to states, tribes, localities, and the regulated community;
   
• Streamlined the effectiveness and efficiency of EPA;
   
• Launched cross-agency initiatives to improve risk communication on emerging contaminants and vulnerable populations;
   
• Initiated multiple actions to reduce lead exposure, including releasing the Federal Lead Action Plan;
   
• Improved enforcement compliance and assistance;
   
• Held EPA’s first-ever Per- and Polyfluoroalkyl Substances (PFAS) National Leadership Summit and Inaugural Recycling Day Summit;
   
• Led international environmental efforts, including first-ever articles to prevent and reduce marine litter; and
   
• Ensured comprehensive and coordinated responses to multiple natural disasters.
   

The YIR provides the following “by the numbers” summary:

• Regulatory Reform: EPA issued 13 final deregulatory actions in 2018. To date, under President Trump, EPA has issued 33 final major deregulatory actions, “saving Americans almost $2 billion”;
   
• Air: EPA reported that, during President Trump’s first year in office, greenhouse gas emissions from major industrial sources decreased by 2.7 percent;
   
• Water: By the end of 2018, EPA closed seven Water Infrastructure Finance and Innovation Act (WIFIA) loans totaling nearly $2 billion to help finance over $4 billion for water infrastructure projects and create up to 6,000 jobs;
   
• Land: EPA deleted all or part of 22 sites from Superfund’s National Priorities List in fiscal year (FY) 2018 -- “the largest number of deletions in one year since FY 2005”;
   
• Chemicals: After inheriting a “backlog” of 672 new chemical submissions pending review in January 2017, under President Trump, EPA “aggressively worked to improve the review of new chemical submissions and, as a result, eliminated the initial backlog and reduced the number of cases pending review to 475 submissions by August 2018.” EPA completed 99.7 percent of the 2,199 pesticide registration actions on-time, and registered 23 new active ingredients and 147 new uses of existing pesticides, “providing new tools to growers to meet their pest management needs”;
   
• Enforcement: In FY 2018, EPA enforcement actions required the treatment, disposal, or elimination of 809 million pounds of pollutants and waste -- almost twice as much as FY 2017. EPA also entered into the largest settlement in the history of its enforcement of the Risk Management Program with the responsible party spending $150 million on major safety improvements; and
   
• Grants: EPA awarded $4,451,520,905 in grants in FY 2018, including more than $63 million under the General Assistance Program, benefiting nearly all federally recognized tribes through awards to 500 tribal governments and approximately 25 intertribal consortia, $4.344 million in State and Tribal Assistance Grants, and 37 environmental education grants totaling $3,306,760 in 32 states to 13 colleges and universities, 23 stakeholder organizations, and one tribal community.
   

Water

As reported in our December 11, 2018, memorandum, “EPA Releases ‘Waters of the U.S.’ (WOTUS) Replacement Rule Proposal,” on December 11, 2018, EPA Acting Administrator Andrew Wheeler announced EPA’s and the U.S. Army Corps of Engineers’ (Corps) release of their highly anticipated proposed replacement WOTUS definition that defines the scope of waters and wetlands that fall under federal Clean Water Act (CWA) jurisdiction. The 2018 WOTUS rule proposal is currently available in pre-publication format on EPA’s website here, along with several fact sheets and other supporting materials. On December 28, 2018, EPA published a Federal Register notice announcing that it would hold a hearing on January 23, 2019, to provide interested parties the opportunity to present data, views, or information concerning the proposed rule. Due to the government shutdown, the January 23, 2019, public hearing was postponed.

Chemicals

In 2018, EPA once again met the deadlines set by the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), which amended the Toxic Substances Control Act (TSCA). EPA staff “worked tirelessly to ensure the most modern and innovative chemicals get to market quickly and safely, providing regulatory certainty for manufacturers and confidence for Americans consumers.”

As reported in our June 22, 2018, memorandum, “EPA Celebrates Anniversary of Lautenberg Act by Releasing Final CBI Guidance, Animal Testing Strategy, and Final Mercury Reporting Rule,” on the two-year anniversary of the Lautenberg Act, EPA announced it had completed the following milestones:

• Final strategy to reduce animal testing: The strategy promotes the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing. It also incorporates input from public meetings and written comments. More information is available in our memorandum, “EPA Releases Final Strategic Plan to Promote the Development and Implementation of Alternative Test Methods Within the TSCA Program.”

• Final rule on reporting mercury manufacturing and imports: According to EPA, it will use the information collected through the new reporting requirements to develop future inventories of mercury and mercury-containing product supply, use, and trade in the U.S. More information is available in our memorandum, “EPA Publishes Final Reporting Requirements for TSCA Mercury Inventory.”

• Guidance for state, tribal, and local governments, and medical personnel and emergency responders on sharing confidential business information (CBI): These guidances specify the process that will enable other governmental entities and medical and emergency personnel to request CBI.

• Policy and procedures for assigning unique identifiers to track better information on chemicals while protecting CBI: EPA will apply an identifier to a substance, whose identity is protected as CBI, as well as to other related information or submissions concerning the same substance. EPA states that this will allow the public to connect information related to the same substance, even while the specific identity is protected as confidential.

• Guidance on structurally descriptive generic names: The guidance will allow EPA to share more information with the public about the structure of substances while protecting the confidential elements of the substance’s specific chemical identity. TSCA submitters claiming the specific chemical identity of a chemical substance as CBI are required to supply a structurally descriptive generic name that can be disclosed to the public. More information is available in our memorandum, “EPA Issues Guidance on Creating Generic Names for Confidential Chemical Substance Identity Reporting under TSCA.”

EPA issued the final of four framework rules under the Lautenberg Act with the final fees rule under TSCA, ensuring that resources are available to EPA to complete chemical reviews and actions in a timely, transparent manner while maintaining high scientific standards. More information is available in our September 28, 2018, memorandum, “EPA Issues Final TSCA Fees Rule.”

EPA released the first ten problem formulation documents, an important interim step prior to completing and publishing the final risk evaluations. The documents refine the scope of risk evaluations for the first ten chemicals selected under the Lautenberg Act. More information is available in our June 5, 2018, memorandum, “EPA Takes ‘Three Important Steps’ Intended to Ensure Chemical Safety.” Months following the release, EPA released the draft risk evaluation for Pigment Violet 29 (PV29), one of the first ten chemicals undergoing risk evaluation under TSCA, delivering on its promise to meet the statutory deadlines and ensure the safety of chemicals currently on the market. 

EPA released a number of documents and guidances including:

1. The systematic review approach document, as reported in our June 5, 2018, memorandum, “EPA Takes ‘Three Important Steps’ Intended to Ensure Chemical Safety”;

2. “Points to Consider” guidance, as reported in our June 21, 2018, memorandum, “EPA Issues Final Guidance on Points to Consider When Preparing TSCA New Chemical Notifications”; and

3. Prioritization approach for chemicals in the next group of TSCA risk evaluations, as reported in our October 3, 2018, memorandum, “EPA Releases Working Approach for Identifying Potential Candidate Chemicals for Prioritization under TSCA.”

As reported in our June 5, 2018, memorandum, “EPA Takes ‘Three Important Steps’ Intended to Ensure Chemical Safety,” EPA published a proposed significant new use rule (SNUR) for certain uses of asbestos (including asbestos-containing goods) to ensure that manufacture, import, or processing for these currently unregulated new uses are prohibited unless reviewed and approved by EPA. Previously, according to EPA, “anyone could have resumed the use of asbestos without seeking approval from the Agency. Once finalized, EPA will be closing this loophole.”

Pesticides

In time for the growing season, EPA states that it extended the registration of dicamba for two years to control weeds in fields for cotton and soybean plants genetically engineered to resist dicamba. According to EPA, it tightened the label requirements to ensure that these products can continue to be used effectively while addressing potential concerns to surrounding crops and plants. More information is available in our November 2, 2018, blog item, “EPA Extends Dicamba Products Registered for ‘Over-the-Top’ Use.”

EPA states that it completed 99.7% of the 2,199 Pesticide Registration Improvement Act (PRIA) pesticide registration actions on time, registered 23 new active ingredients, most of which were classified as reduced-risk pesticides, and registered 147 new uses of existing pesticides, providing new tools to growers to meet their pest management needs.

EPA also released a draft policy to reduce the use of animals in testing chemicals that may irritate the skin or cause an allergic reaction. The draft policy describes the science behind the non-animal alternatives that can now be used (in vitro, in silico, in chemico) to identify skin sensitization, which is necessary for pesticide registrations. More information is available in our April 13, 2018, blog item, “EPA Seeks Comment on Draft Interim Science Policy to Reduce Animal Testing for Skin Sensitization.”

Commentary

We applaud EPA’s work and believe the overview offers a useful summary of past accomplishments. The enforcement narrative is timely given some of the unfavorable press the Agency’s efforts have received in the more recent past. Whether EPA can make good on any initiative planned before the shutdown is, of course, unclear as the YIR was written before December 28, 2018. It goes without saying that EPA, and other agencies impacted by the shutdown, will be challenged to stay on track as the new normal is anything but.